Prescription drug · ANDA
telmisartan NDC 67877-482
Telmisartan 20 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-482-05 | 67877048205 | 500 TABLET in 1 BOTTLE (67877-482-05)Marketed from Jul 25, 2019 | |
| 67877-482-30 | 67877048230 | 30 TABLET in 1 BOTTLE (67877-482-30)Marketed from Jul 25, 2019 | |
| 67877-482-90 | 67877048290 | 90 TABLET in 1 BOTTLE (67877-482-90)Marketed from Jul 25, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- telmisartan
- Generic name (nonproprietary)
- telmisartan
- Active ingredients
- Telmisartan — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205150
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 67877-482_3176efce-402d-3398-e063-6294a90a2f27SPL ID 3176efce-402d-3398-e063-6294a90a2f27SPL set ID 29bddc43-2809-4e1f-ae35-2865e15e9bb6RxCUI 205304, 205305, 282755UNII U5SYW473RQUPC 0367877482309, 0367877484303, 0367877483306
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467877048205followed by a unit qualifier and the quantityPackage 67877-0482-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Telmisartan tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors ( 1.2 ) 1.1 Hypertension Telmisartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide v…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205150
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| telmisartan | Telmisartan 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1428 |
| telmisartan | Telmisartan 80 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3798 |
| telmisartan | Telmisartan 40 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-483 |
| telmisartan | Telmisartan 80 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-484 |
| telmisartan | Telmisartan 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-371 |
| telmisartan | Telmisartan 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5682 |
| telmisartan | Telmisartan 80 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8718 |
| telmisartan | Telmisartan 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8440 |
| telmisartan | Telmisartan 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8441 |
| telmisartan | Telmisartan 80 mg/1 | TabletOral | Proficient Rx LP | 63187-951 |